Hikma v. Amarin: Where Is the Line for Induced Patent Infringement?

By Delia Allen

Background

The United States Supreme Court recently addressed the scope of induced infringement in the pharmaceutical context, unanimously holding in Hikma v. Amarin, 146 S. Ct. 1391 (2026), that the generic manufacturer's FDA-approved skinny label and related statements were insufficient to plausibly allege inducement of patent infringement. 

The dispute involved Amarin’s cardiovascular drug Vascepa which was approved for risk reduction indication covered by method-of-use patents. Under the Hatch-Waxman Act, generic manufacturers may seek FDA approval for non-patented uses by omitting patented indications from their labeling through a process known as “skinny label.” Hikma obtained approval for a generic version of Vascepa using a skinny label that excluded Amarin’s patented cardiovascular-risk reduction indication. The skinny-label process allows generic competition to enter the market without directly infringing patents covering specific methods of treatment. However, disputes frequently arise when brand-name companies argue that a generic manufacturer is indirectly encouraging physicians to prescribe the product for patented uses. Hikma, 146 S. Ct. 1391 (2026).

Amarin alleged that Hikma’s press releases, website statements, and other references to its product encouraged physicians to prescribe the drug for uses that were patented, resulting in infringement under 35 U.S.C. § 271(b). The Federal Circuit reviewed the case, concluding that Hikma's public statements could support an inference of encouragement for infringing uses. Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024).

Main Issue

The main issue was whether Amarin plausibly alleged that Hikma induced infringement under 35 U.S.C. § 271(b) by encouraging physicians to use Hikma's lawfully marketed generic drug for a patented indication despite selling the drug only for non-patented uses.

Holding

The Supreme Court reversed the Federal Circuit’s holding and held that Amarin failed to plausibly allege induced infringement. The Court emphasized that a manufacturer cannot be held liable for inducement merely because physicians may independently prescribe a generic product for patented uses. Instead, the plaintiff must plausibly allege affirmative conduct that specifically encourages or promotes infringement.

Reasoning

The Court found that Hikma's FDA-compliant skinny label, combined with ordinary marketing statements identifying the product as a generic version of Vascepa, did not adequately demonstrate the active steps required for induced infringement. The Supreme Court outlined under §271(b) there are three elements required to constitute induced infringement; “direct infringement by a third party. . . knowledge that the induced acts constitute patent infringement . . . active steps to encourage direct infringement.” 146 S. Ct. 1391, (2026). The decision clarifies that generic drug manufacturers cannot be held liable for induced patent infringement based solely on ordinary references to a branded drug. Instead, there must be active and purposeful conduct showing a specific intent to encourage another party's infringement.

This decision is likely to become a leading authority on induced infringement in the pharmaceutical context. The ruling confirms that compliance with the FDA's skinny-label process remains an important factor in evaluating inducement claims and signals that courts should be cautious before inferring intent from ordinary marketing conduct. Going forward, patentees will likely need stronger evidence that a generic manufacturer actively encouraged infringing use rather than merely selling a product that could be prescribed in an infringing manner.

As a result of this ruling, courts will likely require stronger evidence that a generic manufacturer intentionally encouraged infringement to demonstrate specific intent with active steps before allowing such claims to proceed.

References 

Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391 (2026).
Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024).
https://www.usnews.com/news/top-news/articles/2026-06-04/us-supreme-court-backs-generic-drugmaker-in-skinny-label-patent-case